Verona Pharma(VRNA)

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Verona Pharma(VRNA) - 2021 Q3 - Quarterly Report
2021-11-09 13:53
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM __________ TO __________ Commission File Number: 001-38067 Verona Pharma plc (Exact name of Registrant as specified in its Charter) United Kingdom 98-1489389 (State ...
Verona Pharma (VRNA) Investor Presentation - Slideshow
2021-08-13 19:31
Nasdaq: VRNA | www.veronapharma.com Developing innovative therapies for the treatment of respiratory diseases August 2021 Breath of Innovation™ Forward-looking statements This presentation contains "forward‐looking" statements that are based on the beliefs and assumptions and on information currently available to management of Verona Pharma plc (together with its consolidated subsidiaries, the "Company"). All statements other than statements of historical fact contained in this presentation are forward-look ...
Verona Pharma(VRNA) - 2021 Q2 - Earnings Call Transcript
2021-08-07 14:28
Verona Pharma plc (NASDAQ:VRNA) Q2 2021 Earnings Conference Call August 5, 2021 8:30 AM ET Company Participants David Zaccardelli - President and CEO Mark Hahn - CFO Kathy Rickard - CMO Chris Martin - VP, Commercial Conference Call Participants Suji Jeong - Jefferies Sung Hong - BTIG Operator Welcome to Verona Pharma's Second Quarter 2021 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a listen-only mode. Earlier this morning, Verona Pharma issued a press re ...
Verona Pharma(VRNA) - 2021 Q2 - Quarterly Report
2021-08-05 20:04
[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Verona Pharma plc's unaudited condensed consolidated financial statements as of June 30, 2021, including balance sheets, statements of operations, statements of shareholders' equity, and cash flows, along with notes detailing accounting policies and the Nuance Pharma collaboration [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2021, total assets increased to **$218.5 million** from **$204.2 million** at year-end 2020, primarily due to new receivables from the Nuance agreement, while cash and cash equivalents decreased to **$146.0 million**, and total liabilities rose significantly to **$64.1 million** due to deferred revenue Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $146,035 | $187,986 | | Total current assets | $216,283 | $202,504 | | Total assets | $218,502 | $204,206 | | Deferred revenue | $40,051 | $0 | | Total liabilities | $64,105 | $19,352 | | Total shareholders' equity | $154,397 | $184,854 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a significantly higher net loss for both the three and six months ended June 30, 2021, with the six-month net loss doubling to **$43.4 million**, driven by substantial increases in research and development and general and administrative expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Research and development | $34,137 | $15,433 | | General and administrative | $17,267 | $10,034 | | Operating loss | $(51,404) | $(25,467) | | Net loss | $(43,358) | $(21,384) | | Loss per ordinary share | $(0.09) | $(0.20) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2021, net cash used in operating activities more than doubled to **$38.8 million**, reflecting higher operating losses, resulting in a net decrease in cash and cash equivalents of **$42.0 million** Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,756) | $(16,285) | | Net cash provided by investing activities | $0 | $9,787 | | Net cash used in financing activities | $(3,399) | $0 | | Net decrease in cash and cash equivalents | $(41,951) | $(8,068) | | Cash and cash equivalents at end of period | $146,035 | $22,360 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail key events and accounting policies, most notably the collaboration and license agreement with Nuance Pharma, effective June 9, 2021, which provides **$40 million** in upfront consideration for rights to ensifentrine in Greater China, with revenue expected in Q3 2021 - Entered into a collaboration and license agreement with Nuance Pharma for ensifentrine in Greater China, receiving an unconditional right to **$40.0 million** in upfront consideration (**$25.0 million** cash and a **$15.0 million** equity interest), with eligibility for up to **$179.0 million** in future milestone payments[61](index=61&type=chunk) - The **$40.0 million** in upfront consideration from the Nuance Agreement was recorded as deferred revenue as of June 30, 2021, and is expected to be recognized as revenue in the third quarter of 2021[68](index=68&type=chunk)[72](index=72&type=chunk) - Ligand has claimed it is owed a **25%** sublicense payment on the **$40.0 million** upfront consideration from the Nuance Agreement, which Verona Pharma disputes, stating it has not granted a sublicense of Ligand's intellectual property[74](index=74&type=chunk) - The company has an at-the-market (ATM) offering program to sell up to **$100.0 million** in ADSs, having raised approximately **$0.4 million** during Q2 2021, with **$99.6 million** remaining available[29](index=29&type=chunk)[30](index=30&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on the clinical development of its lead candidate, ensifentrine, for COPD, highlighting increased operating expenses due to Phase 3 trials, the financial impact of the Nuance Pharma collaboration, and a liquidity position deemed sufficient through at least 2023 [Overview and Clinical Development](index=20&type=section&id=Overview%20and%20Clinical%20Development) The company is advancing its Phase 3 ENHANCE trials for ensifentrine in COPD, but patient recruitment timelines are under pressure due to COVID-19 challenges, potentially delaying top-line data reporting from 2022 to Q3 and Q4 2022 for ENHANCE-2 and ENHANCE-1, respectively - The company is focused on developing ensifentrine, a potential first-in-class, inhaled dual inhibitor of PDE3 and PDE4, for respiratory diseases, with Phase 3 ENHANCE trials for COPD underway[89](index=89&type=chunk) - Patient recruitment for the Phase 3 ENHANCE program faces pressure from COVID-19 challenges, with mitigation strategies, such as allowing a subset of patients on ICS to enroll, having been implemented[92](index=92&type=chunk) - Top-line data reporting is projected for H1 2022 (ENHANCE-2) and H2 2022 (ENHANCE-1), but could be delayed to Q3 and Q4 2022, respectively, if COVID-19 challenges persist[93](index=93&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Operating results for the three and six months ended June 30, 2021, show a substantial increase in net loss compared to 2020, with the six-month net loss growing to **$43.4 million** from **$21.4 million**, primarily due to an **$18.7 million** increase in R&D costs for the Phase 3 ENHANCE program and a **$7.3 million** increase in G&A costs Comparison of Operations - Three Months Ended June 30 (in thousands) | Metric | 2021 | 2020 | Variance | | :--- | :--- | :--- | :--- | | Research and development | $20,563 | $7,811 | $12,752 | | General and administrative | $7,985 | $3,172 | $4,813 | | Net loss | $(22,068) | $(9,038) | $(13,030) | Comparison of Operations - Six Months Ended June 30 (in thousands) | Metric | 2021 | 2020 | Variance | | :--- | :--- | :--- | :--- | | Research and development | $34,137 | $15,433 | $18,704 | | General and administrative | $17,267 | $10,034 | $7,233 | | Net loss | $(43,358) | $(21,384) | $(21,974) | [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2021, the company had **$146.0 million** in cash and cash equivalents, and management believes these funds, combined with the **$25 million** upfront payment from Nuance, expected UK tax credits, and available term loan funds, are sufficient to fund operations through at least 2023 - The company believes its cash position as of June 30, 2021, along with the Nuance upfront payment, tax credits, and available debt financing, will fund planned operating expenses through at least 2023[170](index=170&type=chunk) - An at-the-market (ATM) program is in place to sell up to **$100.0 million** of ADSs; as of June 30, 2021, **$99.6 million** remained available for sale[167](index=167&type=chunk)[168](index=168&type=chunk) - The company has a term loan facility of up to **$30.0 million** with Silicon Valley Bank, with **$5.0 million** in principal outstanding as of June 30, 2021, and further advances contingent on achieving clinical milestones[169](index=169&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Verona Pharma is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company as defined in Rule 12b-2 of the Exchange Act and is not required to provide quantitative and qualitative disclosures about market risk[179](index=179&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2021, while noting the need to implement new controls over financial reporting related to the Nuance Agreement - The principal executive officer and principal financial officer concluded that as of June 30, 2021, the company's disclosure controls and procedures were effective at a reasonable assurance level[181](index=181&type=chunk) - Due to the new Nuance Agreement, the company will be required to implement certain new controls over financial reporting in the year ending December 31, 2021[182](index=182&type=chunk) [PART II - OTHER INFORMATION](index=34&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently subject to any material legal proceedings - As of the reporting date, the company is not a party to any material legal proceedings[183](index=183&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section introduces a new material risk factor related to the collaboration and license agreement with Nuance Pharma, highlighting the company's dependence on Nuance Pharma for the development and commercialization of ensifentrine in Greater China - A new risk factor has been identified concerning the collaboration with Nuance Pharma, where the company's business could be adversely affected if Nuance Pharma fails to develop and commercialize ensifentrine in Greater China or if the agreement is terminated[185](index=185&type=chunk) - The company is dependent on Nuance Pharma's efforts and resource allocation for success in the Greater China market, and interests between the two companies may differ or conflict[189](index=189&type=chunk) - The company faces significant competition in seeking other strategic collaborators for ensifentrine, and failure to secure such partnerships could curtail or delay development and commercialization programs[191](index=191&type=chunk)[192](index=192&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=36&type=section&id=Other%20Items%20(Items%202,%203,%204,%205,%206)) This section confirms standard disclosures, reporting no unregistered sales of equity securities, no defaults upon senior securities, no mine safety disclosures, and provides a list of exhibits filed with the 10-Q - Item 2: No unregistered sales of equity securities[194](index=194&type=chunk) - Item 3: No defaults upon senior securities[195](index=195&type=chunk) - Item 6: A list of exhibits filed with the report is provided, including the Collaboration and License Agreement with Nuance Pharma[200](index=200&type=chunk)
Verona Pharma(VRNA) - 2021 Q1 - Earnings Call Transcript
2021-05-01 11:17
Verona Pharma plc (NASDAQ:VRNA) Q1 2021 Earnings Conference Call April 29, 2021 9:00 AM ET Company Participants David Zaccardelli - President and CEO Mark W. Hahn - CFO Kathleen Rickard - CMO Christopher Martin - VP, Commercial Conference Call Participants Suji Jeong - Jefferies Liana Moussatos - Wedbush Securities Edward Nash - Canaccord Genuity Miguel Coelho - Truist Securities Operator Welcome to Verona Pharma's First Quarter 2021 Financial Results and Operating Highlights Conference Call. At this time, ...
Verona Pharma(VRNA) - 2021 Q1 - Quarterly Report
2021-04-29 11:43
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM __________ TO __________ Commission File Number: 001-38067 Verona Pharma plc (Exact name of Registrant as specified in its Charter) United Kingdom 98-1489389 (State or o ...
Verona Pharma(VRNA) - 2020 Q4 - Earnings Call Transcript
2021-02-27 01:44
Verona Pharma plc (NASDAQ:VRNA) Q4 2020 Earnings Conference Call February 25, 2020 9:00 AM ET Company Participants David Zaccardelli - CEO Mark Hahn - CFO Kathy Rickard - CMO Chris Martin - VP, Commercial Conference Call Participants Tom Shrader - BTIG Suji Jeong - Jefferies Andreas Argyrides - Wedbush Securities Joon Lee - Truist Securities Operator Welcome to Verona Pharma's Fourth Quarter and Year End 2020 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a ...
Verona Pharma(VRNA) - 2020 Q4 - Earnings Call Presentation
2021-02-26 18:18
Ensifentrine: A Novel Respiratory Therapy - Ensifentrine is a Phase 3, first-in-class candidate for unmet respiratory needs, acting as an inhaled PDE3 and PDE4 inhibitor[4] - Clinical trials involving over 1300 subjects showed a safety profile similar to placebo[4, 14] - Ensifentrine impacts 3 key mechanisms in respiratory disease: airway smooth muscle, inflammatory cells, and epithelial cells[9] - Phase 2b data showed statistically significant and clinically meaningful improvements in lung function with the 3 mg dose[14] - Phase 2b trials also demonstrated statistically significant and clinically meaningful improvements in symptoms and Quality of Life measures[14] Market Opportunity and Commercialization - The total US sales of chronic maintenance COPD therapies is $96 billion[4] - There are 12 million US COPD patients failing despite maximum therapy[4] - The average annual WAC price of existing nebulized COPD drugs is $12000[59, 66] - Over 85% of lives will be covered by payers, with the remainder through Medical Exception[63] Financial Status - As of December 31, 2020, Verona Pharma had $1880 million in cash and equivalents[73] - Operating expenses for FY 2020 were $743 million[73]
Verona Pharma(VRNA) - 2020 Q4 - Annual Report
2021-02-25 13:29
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM __________ TO __________ Commission File Number: 001-38067 (Exact name of Registrant as specified in its Charter) United Kingdom 98-1489389 (State or other jurisdiction of in ...
Verona Pharma(VRNA) - 2020 Q3 - Earnings Call Transcript
2020-11-01 14:25
Verona Pharma plc (NASDAQ:VRNA) Q3 2020 Earnings Conference Call October 29, 2020 9:00 PM ET Company Participants David Zaccardelli - CEO Mark Hahn - CFO Kathy Rickard - CMO Chris Martin - VP, Commercial Conference Call Participants Joon Lee - Truist Securities Suji Jeong - Jefferies Tom Shrader - BTIG Edward Nash - Canaccord Genuity Operator Welcome to the Verona Pharma Third Quarter 2020 Financial Results and Operating Highlights Conference Call. At this time, all participants are in a listen-only mode. E ...